BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTENE MOUTH SPRAY (ORIGINAL)

    MDR report key: 9957366 · Received April 14, 2020

    Report

    Report Number
    3012293198-2020-00020
    Event Type
    Injury
    Date Received
    April 14, 2020
    Report Date
    March 16, 2020
    Manufacturer
    ULTRADENT PRODUCTS INC/ORATECH LLC
    Product Code
    LFD
    PMA / PMN Number
    K123731
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARGUS CASE (B)(4).

    Description of Event or Problem · 1

    THE SPRAY WENT INTO MY THROAT / I KNOW YOU SUPPOSED TO PUT IT ON YOUR TONGUE [ACCIDENTAL DEVICE INGESTION]. IT'S BEEN BURNING EVER SINCE AND WHEN I LOOKED AT IT LOOKED RED / WHEN I BREATHE IT BURNS [BURNING IN THROAT]. IT'S BEEN BURNING EVER SINCE AND WHEN I LOOKED AT IT LOOKED RED [RED THROAT]. CASE DESCRIPTION: THIS CASE WAS REPORTED BY A CONSUMER VIA CALL CENTER REPRESENTATIVE AND DESCRIBED THE OCCURRENCE OF ACCIDENTAL DEVICE INGESTION IN A (B)(6) YEAR OLD FEMALE PATIENT WHO RECEIVED GLYCERIN (BIOTENE MOUTH SPRAY (ORIGINAL)) OROMUCOSAL SPRAY (BATCH NUMBER U8J021, EXPIRY DATE 31ST JULY 2020) FOR DRY MOUTH. ON AN UNKNOWN DATE, THE PATIENT STARTED BIOTENE MOUTH SPRAY (ORIGINAL). ON AN UNKNOWN DATE, AN UNKNOWN TIME AFTER STARTING BIOTENE MOUTH SPRAY (ORIGINAL), THE PATIENT EXPERIENCED ACCIDENTAL DEVICE INGESTION (SERIOUS CRITERIA GSK MEDICALLY SIGNIFICANT), BURNING IN THROAT AND RED THROAT. THE ACTION TAKEN WITH BIOTENE MOUTH SPRAY (ORIGINAL) WAS UNKNOWN. ON AN UNKNOWN DATE, THE OUTCOME OF THE ACCIDENTAL DEVICE INGESTION, BURNING IN THROAT AND RED THROAT WERE UNKNOWN. IT WAS UNKNOWN IF THE REPORTER CONSIDERED THE ACCIDENTAL DEVICE INGESTION TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). THE REPORTER CONSIDERED THE BURNING IN THROAT AND RED THROAT TO BE RELATED TO BIOTENE MOUTH SPRAY (ORIGINAL). THIS REPORT IS MADE BY GSK WITHOUT PREJUDICE AND DOES NOT IMPLY ANY ADMISSION OR LIABILITY FOR THE INCIDENT OR ITS CONSEQUENCES. ADDITIONAL INFORMATION. ADVERSE EVENT INFORMATION WAS RECEIVED VIA CALL CENTER REPRESENTATIVE ON 16 MARCH 2020. CONSUMER REPORTED THAT, "I SPRAYED SOME OF THE SPRAY, THE SPRAY WENT INTO MY THROAT, IT'S BEEN BURNING EVER SINCE AND WHEN I LOOKED AT IT LOOKED RED. I KNOW YOU SUPPOSED TO PUT IT ON YOUR TONGUE BUT ACCIDENTS HAPPENED, WHEN I BREATHE IT BURNS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424345 BIOTENE MOUTH SPRAY (ORIGINAL) ORAL SPRAY LFD ULTRADENT PRODUCTS INC/ORATECH LLC U8J021

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other